Zydus Pharmaceuticals recalls 50mg Chlorpromazine tablets due to potential N-Nitroso Desmethyl Chlorpromazine contamination exceeding safe limits. Rx-only medication with specific lot numbers and expiration dates.
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Zydus Pharmaceuticals is recalling 50mg Chlorpromazine Hydrochloride tablets that may contain unsafe levels of N-Nitroso Desmethyl Chlorpromazine. This chemical could pose health risks if taken as prescribed. Affected products have specific lot numbers and expiration dates.
The tablets may contain N-Nitroso Desmethyl Chlorpromazine at levels above the acceptable intake limit. This chemical is a potential health risk when taken as prescribed, though the exact risk level isn't specified in the recall.
Prescription patients who received the recalled 50mg Chlorpromazine tablets from Zydus Lifesciences Ltd. in India. Those with the specific lot numbers and expiration dates are most at risk.
Check for the product name 'Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle' with the lot numbers Z306326 (expiring 11/30/2025) or Z401155 (expiring 02/28/2026).
Look for the lot numbers Z306326 or Z401155 on the packaging to confirm if your tablets are affected.
The recall states the product may contain unsafe levels of N-Nitroso Desmethyl Chlorpromazine, but the exact risk level isn't specified. Consult your doctor if you have the affected lot numbers.
The recall does not provide specific action steps for affected users. Check with your healthcare provider for guidance.
Check for lot numbers Z306326 (expiring 11/30/2025) or Z401155 (expiring 02/28/2026) on the packaging.
We’ve drafted a message you can send Zydus Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0635-2025 — Zydus Pharmaceuticals Zydus Pharmaceuticals Hello, I own a Zydus Pharmaceuticals that is covered by recall D-0635-2025 from Zydus Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
